1.Development and verification of Chinese dietary exposure evaluation model software.
Pei LIU ; Jing-xin LI ; Jin-fang SUN ; Jianping XUE ; Bing-wei CHEN ; Hong ZHANG ; Xiao-jin YU ; Can-nan WANG ; Bao-jun YUAN ; Yong-jian MA ; Zi-hua TIAN
Chinese Journal of Preventive Medicine 2010;44(3):204-208
OBJECTIVETo develop the dietary exposure evaluation model software accredited of Chinese intellectual property rights and to verify the rationality and accuracy of the results from the probabilistic model in Chinese dietary exposure evaluation model software according to international standards.
METHODSThe software of SAS was used to build various evaluation model based on the data from Chinese dietary survey and the chemical compound in food surveillance and to design an operation interface. The results from probabilistic dietary exposure model for children 2 - 7 years old were compared with that from duplicate portion study of 2-7 years children dietary exposure in Jinhu, Jiangsu province in order to analyze the rationality of model. The results from probabilistic model of dietary exposure were compared with the results from @Risk software to verify the correction of the probabilistic model by using the same data of randomly selected 10 000 study subjects from national dietary survey. While, the mean drift was used as an internal index to illustrate the accuracy of the computation.
RESULTSChinese dietary exposure evaluation software was developed successfully. On the rationality, the results from probabilistic model were lower than that from the point estimation (e.g., cucumber: the result of point estimation of acephate was 4.78 microg x kg(-1) x d(-1), while the results of probabilistic model which was 0.39 microg x kg(-1) x d(-1)). Meanwhile the results from probabilistic model were higher than the results of duplicate portion study (on the P95, the result of probabilistic model of Pb exposure in children was 11.08 microg x kg(-1) x d(-1), while the results of duplicate portion study was 5.75 microg x kg(-1) x d(-1)). On accuracy, the results from @Risk and the probabilistic model were highly consistent (on the P95, the result of probabilistic assessment of acephate diet exposure was 4.27 microg x kg(-1) x d(-1), while the results of duplicate portion study was 4.24 microg x kg(-1) x d(-1)), and the mean drift was of random distribution, the drift region varied from 0.05% to 11.9%.
CONCLUSIONThe results computed by the software of Chinese dietary exposure evaluation model are reliable and reasonable, which is a meaningful step to improve the dietary exposure evaluation technique in China.
Child ; Child, Preschool ; China ; Consumer Product Safety ; Diet ; statistics & numerical data ; Humans ; Models, Statistical ; Software Design ; Software Validation
2.Medical device software requirements and evaluation.
Chinese Journal of Medical Instrumentation 2011;35(5):379-382
This paper introduces the safety and effectiveness requirements of medical device software. And it discusses the methods on evaluating medical device software from two aspects, the design and development process of the software and software products.
Equipment Safety
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Equipment and Supplies
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Software
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Software Validation
3.Computerized system validation of clinical researches.
Charles YAN ; Feng CHEN ; Jia-lai XIA ; Qing-shan ZHENG ; Daniel LIU
Acta Pharmaceutica Sinica 2015;50(11):1380-1387
Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic
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Database Management Systems
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standards
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Information Storage and Retrieval
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standards
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Software Validation
4.Design and implementation of aphasia rehabilitation software based on speech recognition.
Yingjie MA ; Ji CHEN ; Jie SHUAI
Journal of Biomedical Engineering 2006;23(6):1343-1346
A new software therapy instrument is proposed for the rehabilitation of aphasia caused by cerebral disorder, which is different from general drug therapy or physical therapy and is, based on modern speech and biofeedback principles. Aphasia rehabilitation software package on the therapy instrument were designed and implement. The features of the software and its future application were discussed.
Aphasia
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rehabilitation
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Communication Aids for Disabled
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Humans
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Software Design
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Speech Recognition Software
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Speech Therapy
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instrumentation
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methods
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Therapy, Computer-Assisted
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methods
5.Applications of tree-shaped structure in DICOM based on XML.
Chinese Journal of Medical Instrumentation 2006;30(2):83-87
In order to improve the sharing of DICOM, a proposal is offered to introduce XML into DICOM on the SPIE 2005 and in this way, better readability and expansibility of DICOM files have been achieved. On this basis, the DICOM data structure is improved further by replacing the one-dimension linear data structure with multilayer tree-shaped data structure. And thus the nesting and dependence relationships between information object and data elements are much clearer and it is more convenient and easy to browse DICOM image files.
Database Management Systems
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Information Storage and Retrieval
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methods
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standards
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Medical Informatics
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methods
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Medical Records Systems, Computerized
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Programming Languages
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Radiology Information Systems
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Software
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User-Computer Interface
6.Software for MR image reconstruction from data acquired on an irregular k-space trajectory.
Yongxian QIAN ; Lirong LIU ; Kai XU ; Jiarui LIN
Journal of Biomedical Engineering 2003;20(2):322-327
A PC-based software was developed and programmed with VC++6 for reconstructing MR images from the data acquired on an irregular k-space trajectory. It can read clinical MRI raw data and image data, create numerical phantoms, design k-space trajectories, generate k-space data from numerical phantom, calculate weighting functions, reconstruct images, and carry out error analysis for the reconstructed images. It is helpful to the investigations of new k-space trajectories and new reconstruction algorithms.
Algorithms
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Bayes Theorem
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Brain
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anatomy & histology
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Fourier Analysis
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Humans
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Image Processing, Computer-Assisted
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methods
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Magnetic Resonance Imaging
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methods
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Programming Languages
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Software
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Software Design
7.The design of smart data collection system for EHR.
Xue-yi LI ; Zhuang-zhi YAN ; Hai-jiao LV
Chinese Journal of Medical Instrumentation 2009;33(6):421-424
This paper presents the design of smart data collection system to deal with the drawbacks like EHR data second hand input which is time-consuming and EHR's poor usability. The system comprises security certification, information management and data transmission modules. Through WLAN, EHR data can transmit between smart terminals and server. Also it provides a real-time communication platform for both terminal users and medical care personnel.
Computer Security
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Database Management Systems
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Information Systems
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Medical Records Systems, Computerized
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organization & administration
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Software Design
8.Development of a System for Extracting the Information of Candidate Tumor Markers Reported in Biomedical Literatures.
Jeong Min CHAE ; Heung Bum OH ; Sung Eun CHOI ; Choong Hwan CHA ; Myung Hee KIM ; Soon Young JUNG
The Korean Journal of Laboratory Medicine 2008;28(1):79-87
BACKGROUND: Since the human genome project was completed in 2003, there have been numerous reports on cancer and related markers. This study was aimed to develop a system to extract automatically information regarding the relationship between cancer and tumor markers from biomedical literatures. METHODS: Named entities of tumor markers were recognized by both a dictionary-based method and machine learning technology of the support vector machine. Named entities of cancers were recognized by the MeSH dictionary. RESULTS: Relational and filtering keywords were selected after annotating 160 abstracts from PubMed. Relational information was extracted only when one of the relational keywords was in an appropriate position along the parse tree of a sentence with both tumor marker and disease entities. The performance of the system developed in this study was evaluated with another set of 77 abstracts. With the relational and filtering keyword used in the system, precision was 94.38% and recall was 66.14%, while without the expert knowledge precision was 49.16% and recall was 69.29%. CONCLUSIONS: We developed a system that can extract relational information between a tumor and its markers by incorporating expert knowledge into the system. The system exploiting expert knowledge would serve as a reference when developing another information extraction system in various medical fields.
Abstracting and Indexing as Topic
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Algorithms
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Database Management Systems
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Humans
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*Medical Informatics Computing
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Neoplasms/metabolism
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Programming Languages
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*PubMed
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Software
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*Tumor Markers, Biological
9.Development of an ECG signals analysis service system based on B/S.
Qing JIAO ; Yong-Xin GUO ; Dong CUI ; Lin-Lin CHE ; Ji-Min CAO ; Zheng-Guo ZHANG
Chinese Journal of Medical Instrumentation 2008;32(3):203-206
An online ECG signals analysis service system based on the network has been established and is introduced in this paper which integrates the advantages of the network, database and ECG analysis tools, providing on-line ECG signal analysis service. Users with the knowledge of general operation of a browser, can process the ECG data and get a real-time display of analysis results.
Computer Systems
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Database Management Systems
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Databases, Factual
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Electrocardiography
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methods
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Signal Processing, Computer-Assisted
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Software Design
10.Research on the distributed PACS based on grid technology.
Yong-xing LUO ; Li-jun JIANG ; Hai-bo HU ; Tian-ge ZHUANG
Chinese Journal of Medical Instrumentation 2006;30(4):287-290
In this paper, we introduce the grid technology into the design of the distributed PACS. First, we analyse the architecture and functions of OGSA-DAI, and then, introduce a model of the distributed PACS based on OGSA-DAI, and give a detailed analysis on its basic components and workflow. Finally, we make a conclusion on the distributed PACS based on grid technology.
Computer Communication Networks
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Computer Systems
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Database Management Systems
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Humans
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Information Storage and Retrieval
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methods
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Medical Informatics
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Radiology Information Systems
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Software
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Software Design
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Systems Integration